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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K220697
Device Name Nitrile Patient Examination Gloves, Powder Free
Applicant
Lalan Rubbers (Pvt), Ltd.
# 95/B, Zone A, Export Processing Zone, Biyagama
Malwana,  LK EPZ11672
Applicant Contact Renuka Priyangi
Correspondent
Lalan Rubbers (Pvt), Ltd.
# 95/B, Zone A, Export Processing Zone, Biyagama
Malwana,  LK EPZ11672
Correspondent Contact Renuka Priyangi
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/09/2022
Decision Date 09/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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